81 FR 7817 - Notice of Correction
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 30 (February 16, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 30 (February 16, 2016)
| Page Range | 7817-7817 | |
| FR Document | 2016-03106 |
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)] [Notices] [Page 7817] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03106] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Notice of Correction AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice; correction. ----------------------------------------------------------------------- SUMMARY: The Health Resources and Services Administration published a notice in the Federal Register, 80 FR 55861 (September 17, 2015) announcing the Bridging the Word Gap Competition Challenge. This correction notice extends the deadline for Phase 1 submissions by approximately 4 weeks to allow for additional submissions. Accordingly, the remaining timelines for all subsequent phases and judging periods will also be extended by approximately 4 weeks. FOR FURTHER INFORMATION CONTACT: Jessie Buerlein, Public Health Analyst, Maternal and Child Health Bureau, Health Resources and Services Administration, 5600 Fishers Lane Rockville, MD 20852, [email protected], 301-443-8931. Correction In the Federal Register 80 FR 55861 (September 17, 2015), please make the following corrections: In the Summary section, correct dates of each phase to read: Dates for each phase are as follows: Phase 1 Effective: November 6, 2015 Phase 1 Submission Deadline: January 29, 2016, 11:59 p.m. ET Phase 1 Judging Period: January 30-February 28, 2016 Phase 1 Winners Announced: March 8, 2016 Phase 2 Begins: March 11, 2016 Phase 2 Submission Deadline: August 11, 2016 Phase 2 Judging Period: August 12-September 16, 2016 Phase 2 Winners Announced: Week of September 19, 2016 Phase 3 Begins: September 26, 2016 Phase 3 Submission Deadline: March 26, 2017 Phase 3 Winner Announced: May 2017 Dated: January 29, 2016. James Macrae, Acting Administrator. [FR Doc. 2016-03106 Filed 2-12-16; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 7817
the claimed confidential information, in and PAR, has grown markedly in the DEPARTMENT OF HEALTH AND
its consideration of comments. The past decade. The recommendations in HUMAN SERVICES
second copy, which will have the this draft guidance are based on an
claimed confidential information assessment of important issues raised in Health Resources and Services
redacted/blacked out, will be available the review of both adult and pediatric Administration
for public viewing and posted on http:// allergic rhinitis clinical trials and the
www.regulations.gov. Submit both Agency’s current understanding of the Notice of Correction
copies to the Division of Dockets mechanism of the two related disorders
Management. If you do not wish your of SAR and PAR. The pathophysiology AGENCY:Health Resources and Services
name and contact information to be of SAR and PAR are similar in terms of Administration, HHS.
made publicly available, you can the chemical mediators produced and ACTION: Notice; correction.
provide this information on the cover end-organ manifestations, with
sheet and not in the body of your differences between the two entities SUMMARY: The Health Resources and
comments and you must identify this primarily based on the causes and Services Administration published a
information as ‘‘confidential.’’ Any duration of disease. The trial design notice in the Federal Register, 80 FR
information marked as ‘‘confidential’’ issues pertaining to SAR and PAR are 55861 (September 17, 2015) announcing
will not be disclosed except in also similar. Thus, these two categories the Bridging the Word Gap Competition
accordance with 21 CFR 10.20 and other are treated collectively in this draft Challenge. This correction notice
applicable disclosure law. For more guidance as allergic rhinitis, with extends the deadline for Phase 1
information about FDA’s posting of differences in recommendations for the submissions by approximately 4 weeks
comments to public dockets, see 80 FR design of SAR and PAR trials indicated. to allow for additional submissions.
56469, September 18, 2015, or access This draft guidance revises the draft Accordingly, the remaining timelines
the information at: http://www.fda.gov/ guidance for industry entitled ‘‘Allergic for all subsequent phases and judging
regulatoryinformation/dockets/ Rhinitis: Clinical Development periods will also be extended by
default.htm. Programs for Drug Products’’ issued approximately 4 weeks.
Docket: For access to the docket to April 2000. All of the public comments FOR FURTHER INFORMATION CONTACT:
read background documents or the we received for the draft guidance have
electronic and written/paper comments Jessie Buerlein, Public Health Analyst,
been considered and the draft guidance Maternal and Child Health Bureau,
received, go to http:// has been revised as appropriate.
www.regulations.gov and insert the Health Resources and Services
This draft guidance is being issued Administration, 5600 Fishers Lane
docket number, found in brackets in the consistent with FDA’s good guidance
heading of this document, into the Rockville, MD 20852, jbuerlein@
practices regulation (21 CFR 10.115). hrsa.gov, 301–443–8931.
‘‘Search’’ box and follow the prompts The draft guidance, when finalized, will
and/or go to the Division of Dockets represent the current thinking of FDA Correction
Management, 5630 Fishers Lane, Rm. on the development of drug products for
1061, Rockville, MD 20852. In the Federal Register 80 FR 55861
the treatment of allergic rhinitis. It does (September 17, 2015), please make the
Submit written requests for single not establish any rights for any person
copies of this draft guidance to the following corrections:
and is not binding on FDA or the public.
Division of Drug Information, Center for You can use an alternative approach if In the Summary section, correct dates
Drug Evaluation and Research, Food it satisfies the requirements of the of each phase to read:
and Drug Administration, 10001 New applicable statutes and regulations. Dates for each phase are as follows:
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993– II. The Paperwork Reduction Act of Phase 1 Effective: November 6, 2015
0002. Send one self-addressed adhesive 1995 Phase 1 Submission Deadline: January
label to assist that office in processing 29, 2016, 11:59 p.m. ET
This draft guidance refers to
your requests. See the SUPPLEMENTARY Phase 1 Judging Period: January 30–
previously approved collections of
INFORMATION section for electronic February 28, 2016
information that are subject to review by
access to the draft guidance document.
the Office of Management and Budget Phase 1 Winners Announced: March 8,
FOR FURTHER INFORMATION CONTACT: (OMB) under the Paperwork Reduction 2016
Sofia Chaudhry, Center for Drug Act of 1995 (44 U.S.C. 3501–3520). The
Evaluation and Research, Food and Phase 2 Begins: March 11, 2016
collections of information in 21 CFR
Drug Administration, 10903 New part 312 have been approved under Phase 2 Submission Deadline: August
Hampshire Ave., Bldg. 22, Rm. 3317, OMB control number 0910–0014. 11, 2016
Silver Spring, MD 20993–0002, 301– Phase 2 Judging Period: August 12–
796–4157. III. Electronic Access
September 16, 2016
SUPPLEMENTARY INFORMATION: Persons with access to the Internet Phase 2 Winners Announced: Week of
I. Background may obtain the draft guidance at either September 19, 2016
http://www.fda.gov/Drugs/
FDA is announcing the availability of Phase 3 Begins: September 26, 2016
GuidanceCompliance
a draft guidance for industry entitled RegulatoryInformation/Guidances/ Phase 3 Submission Deadline: March
mstockstill on DSK4VPTVN1PROD with NOTICES
‘‘Allergic Rhinitis: Developing Drug default.htm or http:// 26, 2017
Products for Treatment.’’ The purpose of www.regulations.gov. Phase 3 Winner Announced: May 2017
this draft guidance is to assist sponsors
in the development of drug and biologic Dated: February 9, 2016. Dated: January 29, 2016.
products for the treatment of SAR and Leslie Kux, James Macrae,
PAR. Information about the Associate Commissioner for Policy. Acting Administrator.
pathophysiology and treatment of [FR Doc. 2016–02978 Filed 2–12–16; 8:45 am] [FR Doc. 2016–03106 Filed 2–12–16; 8:45 am]
allergic rhinitis and its subtypes, SAR BILLING CODE 4164–01–P BILLING CODE 4165–15–P
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Document Created: 2016-02-13 03:13:13
Document Modified: 2016-02-13 03:13:13
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice; correction. | |
| Contact | Jessie Buerlein, Public Health Analyst, Maternal and Child Health Bureau, Health Resources and Services Administration, 5600 Fishers Lane Rockville, MD 20852, [email protected], 301-443-8931. | |
| FR Citation | 81 FR 7817 |
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